In its last session the Texas Legislature passed a new law concerning Pain Management Clinics. The law, which becomes effective on September 1, 2010, makes it illegal to own / operate a Pain Management Clinic in Texas without first obtaining a certificate from the Texas Medical Board. Although it appears benign enough at first blush, upon closer review of its certification requirements the law’s fairly draconian nature comes into focus.

The new law bars individuals and entities from certification in any of a long list of circumstances. To summarize, if the owner/operator of a pain management clinic, their employee, or any person or entity who contracts with such a clinic have any of the following in their record, they are not eligible for certification by the Medical Board:

1)      Any individual who has had restrictions placed on or been denied a certificate or license by any federal or state agency authorizing them to prescribe, administer, supply, or sell a controlled substance;

2)      Any person who has been subject to a disciplinary action by a licensing entity (such as the Texas Medical Board) for conduct relating to the inappropriate prescribing, dispensing, administering, supplying, or selling of a controlled substance.

3)      Any individual who has been convicted of, pled no contest to, or received deferred adjudication for any felony;

4)       Any individual who has been convicted of, pled no contest to, or received deferred adjudication for a misdemeanor when the underlying conduct relates to the distribution of illegal prescription drugs or a controlled substance as defined in the Medical Practice Act.

In a single stroke this new regulation threatens to close numerous independent pain clinics in Texas. In my experience it seems overly burdensome, strict, and unreasonable to issue such blanket restrictions on those involved in pain management. This is especially true as those physicians whose primary practice involves the treatment of chronic pain are typically subject to some of the greatest scrutiny by the Medical Board. The TMB has a decidedly conservative view on pain medicine and this is reflected in the number of Board Orders and other disciplinary actions which focus on this area.  The new law has a “one strike and you’re out” mentality that does not provide for second chances, the opportunity to redeem oneself, or provide for the possibility that a previous disciplinary action may have been unwarranted or even plain wrong. All a physician needs is a single mark on their record where the Board disagreed with their treatment or prescription plan for a single patient and they will be barred from receiving a certification. Owner’s face a particularly onerous burden as the slightest infraction by one of their workers or contractors in or outside the workplace could mean the loss of the clinic’s certificate and, thus, their business.

I find it regrettable that nothing in the law permits a Pain Management Clinic currently in operation to be “grandfathered in” and given a certificate. Even if clinic has years of demonstrated compliance with all previous rules and regulations its owner could still be denied a certificate and immediately shut down if any of the stipulations above apply. Meaning, that on September 1, 2010, many owners with past infractions may lose their business outright, and those owners who have never faced disciplinary actions will now be faced with firing valuable and loyal employees or contractors who regrettably made mistakes in their past. This is especially troubling as physicians who signed Agreed Orders or accepted plea deals years in the past now face a serious consequence which was completely unforeseen at the time. If these individuals had know the future effect of such settlements, they may been chosen to more strenuously contest past allegations.

The only recourse for a Pain Management Clinic who will not be able to meet the criteria for certification is to attempt to restructure their business so they can meet one of the specified exemptions. In addition to state and federal facilities, the new law exempts hospitals, including outpatient facilities and clinics, as well as hospices. Realistically, the only real option available is sell or rearrange the clinic so that it is a subdivision of a local hospital. This pain management laws also raises potential federal preemptions issues depending on how it is enforced by the Medical Board.

It is unclear what will be the final impact of the new credentialing requirements. What can be said with confidence, however, is that pain management clinics have become a highly regulated sphere in Texas.